Safety and Efficacy of Remimazolam in OPCAB Surgery

Coronary Artery Bypass Surgery Clinical Trial

Official title:

Safety and Efficacy of Remimazolam in Induction and Maintenance of General Anesthesia in OPCAB Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05396690
• Other study ID #: AJIRB-MED-INT-21-641
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: June 2022
• Source: Ajou University School of Medicine
• Contact: ji young yoo
• Phone: 01056902104
• Email: anesyoo[@]aumc.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Remimazolam is a novel short-acting benzodiazepine drug that acts on the benzodiazepine binding site of gamma-aminobutryic acid (GABA) A receptor, is metabolized by esterase, and has a context-sensitive half-time of about 6-7 minutes. Looking at some previous studies using Remimazolam, the safety and efficacy as a general anesthetic have been sufficiently proven.

In particular, compared to intravenous anesthetic agents such as propofol, the action time of anesthetics is relatively longer, but the frequency of hypotension is low. However, most studies have been conducted on patients of American Society Anesthesiologist (ASA) class I-II, and studies on patients with high severity have not yet been sufficiently secured.

Therefore, this study aims to compare the efficacy and safety of Remimazolam as an anesthetic with Sevoflurane in terms of hemodynamics in patients with high severity undergoing OPCAB surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 94
• Est. completion date: September 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Adult patients 19 years of age or older to receive OPCAB surgery

• Clinical diagnosis of coronary artery obstructive disease

Exclusion Criteria:

• Ejection fraction < 35% at preoperative ECHO test

• Mitral regurgitation > grade 2 at preoperative ECHO test

• Currently using inotropics

• Currently receiving mechanical support

Related Conditions & MeSH terms

• Coronary Artery Bypass Surgery

Intervention

Drug:
• Remimazolam Injection [Byfavo]
Induction dose: 6 mg/kg/h with sufentanil Maintenance dose: 1~2 mg/kg/h with sufentanil If arousal occurs during surgery, rapidly increase the infusion rate of remimazolam to 12 mg/kg/h and infuse for 1 minute. If the patient's arousal persists after these measures, stop remimazolam infusion and replace with another drug.
• Sevoflurane
Induction dose: 2~3 mg midazolam with sufentanil Maintenance: Adjust the concentration to be BIS 35-65 based on 0.5 mac If arousal occurs during surgery, raise the concentration of sevoflurane to 1.5 MAC (increase the total gas flow rate to 8 l/min) and if arousal persists after 1 minute, administer midazolam 2-3 mg.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggido

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac index (T4)	The cardiac index (CI) at that time was measured and compared between the two groups.	5 minutes before operation
Primary	cardiac index (T5)	The cardiac index (CI) at that time was measured and compared between the two groups.	10 minutes after starting left internal mammary artery dissection
Primary	cardiac index (T6)	The cardiac index (CI) at that time was measured and compared between the two groups.	10 minutes after starting left anterior descending coronary artery anastomosis
Primary	cardiac index (T7)	The cardiac index (CI) at that time was measured and compared between the two groups.	10 minutes after starting Y-graft anastomosis of graft vessels
Secondary	NE dose	total amount of norepinephrine during OPCAB	During surgery(from induction of anesthesia to end of surgery)
Secondary	Incidence of hypotension	The incidence of hypotension during OPCAB are counted by number which based on the anesthetic record.	During surgery(from induction of anesthesia to end of surgery)